Effectiveness of combined treatment on cervical spine and masticatory muscles on temporomandibular disorders. A pilot study.

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12616001327471
• Date of registration: 22/09/2016
• Prospective Registration: No
• Primary sponsor: Universidad Alcala de Henares
• Public title: Effectiveness of combined treatment on cervical spine and masticatory muscles on temporomandibular disorders. A pilot study.
• Scientific title: Effectiveness of combined treatment on cervical spine and masticatory muscles on temporomandibular disorders. A Randomized Controlled Trial.
• Date of first enrolment: 06/02/2016
• Target sample size: 60
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12616001327471.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Open (masking not used);Type of endpoint: Efficacy;

Countries of recruitment

Spain

Contacts

• Name: Miss Sandra García Valero

• Name: Mr Guillermo Gil Palop

Key inclusion & exclusion criteria

Inclusion criteria: Patients diagnosed with temporomandibular disorder.
Exclusion criteria: Patients with presence of other pathologies than musculoskeletal, either genetic (Down syndrome, etc.) or neurological (ICTUS, etc.). Patients that have not been treated by dry needling any time before.

Age minimum: 20 Years
Age maximum: 50 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Musculoskeletal - Other muscular and skeletal disorders

Temporomandibular disorders;
Temporomandibular disorders

Physical Medicine / Rehabilitation - Physiotherapy

Intervention(s)

In this trial, patients with Temporomandibular Disorders are randomly assigned to one of four groups (three of them are treatment, and the other one is placebo). The first treatment group receives postero-anterior slow mobilizations in high cervical spine (C2) in four sets of 45 seconds each, with 15 seconds rest in between each set. The second one receives dry-needling in masseter muscle until the patient tolerates or during 60 seconds maximum. The third one receives both treatments. The treatments were administrated by two accredited physiotherapists with 2 and 5 years of experience.
The treatment is based in two sessions spaced two weeks apart. Prior to each treatment session, pain intensity (Visual Analog Scale), pressure sensitivity (with Algometer) and maximum mouth opening (mm interincisor distance) are measured. Furthermore, there is a follow-up assessment, four weeks after last treatment session, with the same variable measurement. To monitor the adherence to the intervention, it is checked at each session that all the patients have attended.

Primary Outcome(s)

The primary outcome is pain assessed by visual analogue scale.[Immediately prior to first session, at second session (2 weeks after first session), and at third session (one month after second session).]

Secondary Outcome(s)

Pressure sensibility, assessed using mechanical algometer.[Immediately prior to first session, at second session (2 weeks after first session), and at third session (one month after second session).]

The secondary outcome is mouth opening, measured using measuring tape by treating physiotherapist.[Immediately prior to first session, at second session (2 weeks after first session), and at third session (one month after second session).]

Secondary ID(s)

None

Source(s) of Monetary Support

Universidad Alcala de Henares

Ethics review

Status: Approved
Approval date:
Contact:

Comite de Etica de la Investigacion y de Experimentacion animal de la Universidad Alcala de Henares